BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY INDICATOR RED CELLS

    MDR report key: 7268364 · Received February 13, 2018

    Report

    Report Number
    1034569-2018-00042
    Event Type
    Malfunction
    Date Received
    February 13, 2018
    Date of Event
    January 19, 2018
    Report Date
    February 13, 2018
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSF
    UDI-DI
    10888234000600
    PMA / PMN Number
    BK020053
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE FULL NUMBER FOR THE PRODUCT IN QUESTION IS BK020053 ((B)(6) 2003). IMMUCOR TECHNICAL SUPPORT USED A REMOTE ELCTRONIC CONNECTION METHOD ON (B)(6) 2018 TO ASSESS THE INSTRUMENT TEST WELL IMAGE IN QUESTION. IMMUCOR DID A DHR REVIEW ON 26JAN2018, AFTER THE PRODUCT HAD ALREADY EXPIRED, WHICH SHOWED THAT ALL SPECIFICATIONS HAD BEEN MET BEFORE THE PRODUCT WAS RELEASED TO MARKET. (B)(4).

    Description of Event or Problem · 1

    ON 19JAN "2017", A CUSTOMER SITE REPORTED AN UNEXPECTED NEGATIVE ANTIBODY SCREEN WHEN USING CAPTURE-R READY INDICATOR RED CELLS ON A GALILEO ECHO INSTRUMENT, WHEN TESTED ON (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111229 CAPTURE-R READY INDICATOR RED CELLS ANTIGLOBULIN COATED RED CELLS KSF IMMUCOR, INC. 221996 10888234000600

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR